[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646400":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":25,"locations":31,"responsibleParty":61,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":99,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Pavia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OSCC N0M0",null,"Adult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, without regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered.",[13],"Other: Saliva Collection and Biomarker Analysis",{"label":15,"type":10,"description":16,"interventionNames":17},"OSCC N+M0","Adult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, with regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Saliva Collection and Biomarker Analysis","Participants will undergo saliva sample collection using a sterile disposable absorbent salivary swab before any OSCC-specific oncological treatment. Salivary samples will be analyzed to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8\u002FCXCL8, and IL1RN. No experimental treatment will be administered, and the study procedures will not modify the standard diagnostic or therapeutic pathway.",[15,9],[24],"Salivary IL-6 Measurement; Interleukin Gene Polymorphism Analysis",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Matteo Pellegrini, DDS","CONTACT","+39 0382 516209","matteo.pellegrini02@universitadipavia.it",[32,50],{"facility":33,"status":10,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico","Milan","Lombardy","20122","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],9.18951,45.46427,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":10,"email":49},"Giada Anna Beltramini, Associate Professor","+39 02 5503 4422","giada.beltramini@policlinico.mi.it",{"facility":51,"status":10,"city":52,"state":35,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia","Pavia","27100",{"type":40,"coordinates":55},[56,57],9.15917,45.19205,{"lat":57,"lon":56},[60],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Andrea Scribante","Associate Professor, Principal Investigator","100646400","salivary-il-6-and-interleukin-gene-polymorphisms-in-oral-squamous-cell-carcinoma-100646400",false,"NCT07692360","Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma","Salivary Interleukin-6 Levels and Interleukin Gene Polymorphisms for the Biological Stratification of Locoregional Progression in Oral Squamous Cell Carcinoma (OSCC): A Multicentre Observational Cross-Sectional Study","IL6-OSCC","Inclusion Criteria:\n\n* Age 18 years or older\n* Histopathologically confirmed diagnosis of oral squamous cell carcinoma of the oral cavity\n* Oral squamous cell carcinoma site excluding oropharyngeal sites\n* Defined regional lymph node status allowing classification as OSCC N0M0 or OSCC N+M0\n* Absence of distant metastasis, classified as M0\n* Saliva sample collection feasible before any OSCC-specific oncological treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy\n* Suitability for saliva collection using a standardized absorbent swab\n* Availability of biological material for genotyping\n* Ability to provide written informed consent for study participation, biological sampling, and genetic analysis\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Oral squamous cell carcinoma involving oropharyngeal sites\n* Presence of distant metastasis\n* Previous OSCC-specific oncological treatment before saliva sample collection\n* Acute infection at the time of sampling or within the previous 2 weeks\n* Active or inadequately controlled systemic autoimmune or inflammatory disease that may significantly alter cytokine profiles\n* Systemic immunosuppressive or immunomodulatory therapy within the previous 4 to 8 weeks\n* Recent oncological treatment for malignancies other than OSCC within the previous 6 months, if considered potentially interfering with the immune-inflammatory profile\n* Clinically significant acute oral infection or inflammatory process at the time of sampling\n* Active oral bleeding or evident blood contamination of the salivary swab Invasive dental procedures within the previous 2 weeks\n* Systemic antibiotic therapy within the previous 2 weeks\n* Inability to provide written informed consent","ALL","18 Years",{"count":76,"type":77},38,"ESTIMATED","OBSERVATIONAL","This observational study will evaluate whether salivary interleukin-6 levels and selected interleukin gene polymorphisms are associated with regional lymph node involvement in patients with oral squamous cell carcinoma.\n\nAdult patients with histologically confirmed oral squamous cell carcinoma will be enrolled before receiving any cancer-specific treatment. Participants will be classified into two groups according to the presence or absence of regional lymph node metastasis: OSCC N0M0 and OSCC N+M0.\n\nThe study does not involve any experimental treatment and does not change the standard diagnostic or therapeutic pathway. Each participant will provide a saliva sample using a sterile absorbent swab. The saliva sample will be used to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8\u002FCXCL8, and IL1RN.\n\nThe aim of the study is to explore whether these salivary and genetic markers may help characterize different biological patterns of locoregional progression in oral squamous cell carcinoma.",[81],"Oral Squamous Cell Carcinoma (OSCC)",[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98],"Oral squamous cell carcinoma","OSCC","Salivary interleukin-6","IL-6","Interleukin gene polymorphisms","Regional lymph node metastasis","Locoregional progression","Salivary biomarkers","Genetic biomarkers","IL6","IL1B","IL10","IL8","CXCL8","IL1RN","Tumor microenvironment","NOT_YET_RECRUITING","2026-07-02",{"date":102,"type":103},"2026-07-09","ACTUAL",{"date":105,"type":77},"2026-09-01",{"date":107,"type":77},"2028-06-30",{"name":5,"class":6},2]